FDA 510(k) Application Details - K192420

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyamide   More FDA Info for this Device
510(K) Number	K192420
Device Name	Suture, Nonabsorbable, Synthetic, Polyamide
Applicant	Kono Seisakusho Co., Ltd. 3-43-16, Hongo Bunkyo-ku 130-0033 JP Other 510(k) Applications for this Company
Contact	Hiroyuki Arai Other 510(k) Applications for this Contact
Regulation Number	878.5020   More FDA Info for this Regulation Number
Classification Product Code	GAR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/04/2019
Decision Date	05/29/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review